CompletedPhase 1

Study to Evaluate Safety and Tolerability of XmAb13676 (Plamotamab) in Patients With CD20-expressing Hematologic Malignancies

United States154 participantsStarted 2016-10

Plain-language summary

The purpose of this study is to determine the safety and tolerability of intravenous (IV) and subcutaneous (SC) administration of XmAb13676 and to determine the maximally tolerated dose (MTD) and/or recommended dose (RD).

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Histologically confirmed diagnosis (specified by 2016 World Health Organization) of DLBCL or transformed low-grade lymphoma with measurable disease
✓. Patient must be refractory or have relapsed after 2 or more standard therapeutic options, at least one of which must have included anti-CD20 antibody therapy.
✓. Not a candidate for or refusing treatment with hematopoietic stem cell transplantation
✓. Diagnosis of follicular lymphoma Grades 1-3a
✓. Patient must be ineligible for or have exhausted standard therapeutic options and have had 2 or more prior systemic regimens.

What they're measuring

Safety and tolerability as determined by the number of participants with treatment-related adverse events as assessed by CTCAE v4.03

Timeframe: Baseline Day 1 through Day 56

Identify maximum tolerated (MTD) and/or recommended dose (RD) and schedule for XmAb13676 dosing

Timeframe: Baseline Day 1 through Day 56

Trial details

NCT IDNCT02924402

SponsorXencor, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-04

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